GlycoMimetics(US:GLYC)2023-08-02 12:30Financial Performance - The company reported an accumulated deficit of $438.2 million as of June 30, 2023, and anticipates continued significant operating losses over the next several years[101]. - No revenue was recognized during the three and six months ended June 30, 2023, compared to $75,000 in revenue during the same periods in 2022, representing a 100% decrease[117]. - Research and development expenses for the three months ended June 30, 2023, were $4.1 million, a decrease of $3.9 million (49%) compared to $8.0 million in 2022[116]. - General and administrative expenses decreased by $0.6 million (11%) to $4.9 million for the three months ended June 30, 2023, compared to $5.5 million in 2022[120]. - Interest income increased significantly by $0.6 million (680%) to $0.7 million for the three months ended June 30, 2023, compared to $0.1 million in 2022[121]. - Research and development expenses for the six months ended June 30, 2023, were $9.5 million, a decrease of $8.1 million (46%) compared to $17.6 million in 2022[118]. - The company has not generated any revenue from the sale of drug candidates and does not expect to do so in the near future[108]. - For the six months ended June 30, 2023, net cash used in operating activities was $(18,582) thousand, a decrease from $(29,929) thousand in the same period of 2022[136]. - The company reported net cash provided by financing activities of $28,761 thousand during the six months ended June 30, 2023, primarily from sales of common stock under its at-the-market facility with Cowen[139]. - The net change in cash and cash equivalents for the six months ended June 30, 2023, was an increase of $10,166 thousand, compared to a decrease of $(30,011) thousand in the same period of 2022[136]. - The company expects its existing cash and cash equivalents will fund operating expenses into late fourth quarter of 2024, although this estimate is based on assumptions that may prove incorrect[135]. - The company may require additional capital beyond currently anticipated amounts, which may not be available on reasonable terms[132]. Clinical Development - The lead drug candidate, uproleselan, is being evaluated in a Phase 3 clinical trial with 388 patients enrolled, focusing on acute myeloid leukemia (AML)[88]. - An interim analysis of the Phase 3 trial was conducted, with the Independent Data Monitoring Committee recommending continuation towards the final overall survival events trigger[90]. - The company expects to report topline results from the pivotal Phase 3 trial by the end of Q2 2024[91]. - A Cooperative Research and Development Agreement with the National Cancer Institute is in place for a Phase 2/3 trial testing uproleselan in combination with standard chemotherapy, with 267 patients enrolled in the Phase 2 portion[92]. - The company has initiated a Phase 1a trial for GMI-1687, an innovative E-selectin antagonist, expected to start in Q3 2023[96]. - The company is advancing preclinical-stage programs, including GMI-2093, targeting fibrosis and oncology indications[97]. - The company incurred ongoing clinical costs associated with its uproleselan clinical development programs, impacting cash used in operating activities[137]. - The company has entered into various agreements with third-party vendors for clinical trials and manufacturing, which include cancellable terms[128]. Operational Overview - The company has financed operations primarily through private placements and collaboration agreements, with no approved drugs currently available for sale[100]. - The company retains rights for uproleselan and GMI-1687 outside of Greater China, where Apollomics is responsible for development and commercialization[103]. - The company has received a total of $10 million in upfront and milestone payments from Apollomics, with potential further milestone payments totaling approximately $179 million[103]. - The company anticipates an increase in general and administrative expenses in the future as it undertakes commercialization efforts for uproleselan[115]. - The company expects research and development expenses to increase over the next several years as it progresses its drug candidates through clinical development[112]. - As of June 30, 2023, the company had $58.0 million in cash and cash equivalents[122]. - As of June 30, 2023, the company has total remaining lease obligations of $1.4 million under a non-cancelable lease for its office space in Rockville, Maryland, which extends through January 2025[127]. - The company has no fixed long-term obligations and does not anticipate significant capital expenditure requirements[127].